How to Become an Effective GMP Auditor – Part 3

Description:

Periodically Auditing for Good Manufacturing Practice (GMP) observance is a regulatory requirement. This not only involves a methodical understanding of the regulations, but also an insight into how they are being applied. This course gives you detailed information on various aspects of carrying out an audit efficiently and also helps you to improve your skill set to ensure you get the best out of each audit. Remember, effective auditing is an acquired skill—one that requires lots of hard work!

Curriculum For This Course:

Introduction

Overview

1 min 42 secs

Learning objectives

1 min 30 secs

Who should take this course?

1 min 50 secs

Course modules

1 min 38 secs

Module 1: Introduction to GMP Auditing

What is an audit?

1 min 50 secs

Why GMP audit?

2 min 11 secs

Safety, business and compliance

1 min 13 secs

Types of GMP audits

2 min 29 secs

Internal audit (Self inspection)

1 min 56 secs

Regulatory audits

1 min 44 secs

Who conducts GMP audits?

2 min 34 secs

Key principles of GMP audits – Auditors

1 min 26 secs

Key Principles of GMP audits – Process

1 min 37 secs

Benefits of GMP audits

2 min 48 secs

Module 2: The GMP Audit Process

The GMP audit process

1 min 48 secs

Phase 1: Preparation and Planning of the GMP Audit

Determine the basis for the audit

2 min 01 secs

What is the purpose of the audit?

1 min 15 secs

What is your role?

1 min 39 secs

What are the standards?

2 min 02 secs

What is the scope?

1 min 21 secs

Determine the feasibility of the audit

1 min 31 secs

Review documents

1 min 39 secs

Prepare the audit plan

2 min 20 secs

Audit plan communication

1 min 33 secs

Prepare work documents

1 min 50 secs

Phase 2: Performing the Quality Audit

The audit process

1 min 29 secs

The opening meeting

2 min 10 secs

Avoid unproductive meetings

1 min 10 secs

The site area tour

1 min 36 secs

Collect information

1 min 42 secs

Interviews

1 min 51 secs

Records review

1 min 41 secs

Observations

1 min 37 secs

Beginning the conference room pilot

1 min 49 secs

Auditing techniques

1 min 08 secs

Horizontal auditing

2 min 39 secs

Vertical auditing

2 min 07 secs

The ideal combination

1 min 55 secs

Other auditing techniques

1 min 19 secs

General audit findings

2 min 01 secs

The daily wrap up

1 min 47 secs

Classify audit observations

1 min 19 secs

Critical deficiency

1 min 29 secs

Major deficiency

1 min 58 secs

Minor/Other deficiency

1 min 31 secs

The close-out meeting

1 min 39 secs

Phase 3: Preparation, Approval & Distribution of the Audit Report

Preparation of the audit report

1 min 22 secs

Report comments

2 min 39 secs

What should not be in the report

1 min 50 secs

Approve and distribute the audit report

1 min 42 secs

Conduct follow up audit

1 min 58 secs

Phase 4: Audit Closure

Module 3: The System Based Approach

Typical systems

1 min 17 secs

Quality assurance system

2 min 09 secs

Validation / qualification system

1 min 04 secs

Material system

1 min 45 secs

Premises and equipment systems

1 min 51 secs

Packaging and labelling systems

2 min 09 secs

Laboratory control systems (LIMS)

1 min 34 secs

Research and development systems (R&D)

1 min 42 secs

Engineering and maintenance systems

1 min 53 secs

Utilities systems

1 min 16 secs

Warehousing systems

1 min 54 secs

Module 4: The GMP Auditor

How to be a successful auditor

1 min 40 secs

Professional experience

1 min 44 secs

Knowledge and skills

1 min 29 secs

Audit principles

1 min 31 secs

Management systems and references

1 min 22 secs

Organizational situations

1 min 19 secs

Law and regulatory requirements

1 min 55 secs

Personal suitability

1 min 10 secs

Difficult situations

1 min 19 secs

Module 5: Examples of Audit Findings

Examples of GMP non-compliance

1 min 10 secs

Quality systems

1 min 30 secs

Facility systems

1 min 41 secs

Equipment systems

1 min 44 secs

Material systems

1 min 49 secs

Production and process control systems

1 min 51 secs

Packaging and labelling

1 min 30 secs

Laboratory control systems

1 min 22 secs

Organizational and personnel

1 min 15 secs

Records and reports

1 min 58 secs

Returned and salvaged products

1 min 09 secs

Conclusion

Final Assessment

shares

Author

Joginder Mittal

Joginder Mittal is a pharmaceutical GMP Expert with 20 years of extensive experience in cGMP aspects required during designing and setting up of Manufacturing Plants / Laboratories / R & D units. He has been involved in various projects for qualification activities and setting up of QMS Systems

Description:

Periodically Auditing for Good Manufacturing Practice (GMP) observance is a regulatory requirement. This not only involves a methodical understanding of the regulations, but also an insight into how they are being applied. This course gives you detailed information on various aspects of carrying out an audit efficiently and also helps you to improve your skill set to ensure you get the best out of each audit. Remember, effective auditing is an acquired skill—one that requires lots of hard work!

Curriculum For This Course:

Introduction

Overview

1 min 42 secs

Learning objectives

1 min 30 secs

Who should take this course?

1 min 50 secs

Course modules

1 min 38 secs

Module 1: Introduction to GMP Auditing

What is an audit?

1 min 50 secs

Why GMP audit?

2 min 11 secs

Safety, business and compliance

1 min 13 secs

Types of GMP audits

2 min 29 secs

Internal audit (Self inspection)

1 min 56 secs

Regulatory audits

1 min 44 secs

Who conducts GMP audits?

2 min 34 secs

Key principles of GMP audits – Auditors

1 min 26 secs

Key Principles of GMP audits – Process

1 min 37 secs

Benefits of GMP audits

2 min 48 secs

Module 2: The GMP Audit Process

The GMP audit process

1 min 48 secs

Phase 1: Preparation and Planning of the GMP Audit

Determine the basis for the audit

2 min 01 secs

What is the purpose of the audit?

1 min 15 secs

What is your role?

1 min 39 secs

What are the standards?

2 min 02 secs

What is the scope?

1 min 21 secs

Determine the feasibility of the audit

1 min 31 secs

Review documents

1 min 39 secs

Prepare the audit plan

2 min 20 secs

Audit plan communication

1 min 33 secs

Prepare work documents

1 min 50 secs

Phase 2: Performing the Quality Audit

The audit process

1 min 29 secs

The opening meeting

2 min 10 secs

Avoid unproductive meetings

1 min 10 secs

The site area tour

1 min 36 secs

Collect information

1 min 42 secs

Interviews

1 min 51 secs

Records review

1 min 41 secs

Observations

1 min 37 secs

Beginning the conference room pilot

1 min 49 secs

Auditing techniques

1 min 08 secs

Horizontal auditing

2 min 39 secs

Vertical auditing

2 min 07 secs

The ideal combination

1 min 55 secs

Other auditing techniques

1 min 19 secs

General audit findings

2 min 01 secs

The daily wrap up

1 min 47 secs

Classify audit observations

1 min 19 secs

Critical deficiency

1 min 29 secs

Major deficiency

1 min 58 secs

Minor/Other deficiency

1 min 31 secs

The close-out meeting

1 min 39 secs

Phase 3: Preparation, Approval & Distribution of the Audit Report

Preparation of the audit report

1 min 22 secs

Report comments

2 min 39 secs

What should not be in the report

1 min 50 secs

Approve and distribute the audit report

1 min 42 secs

Conduct follow up audit

1 min 58 secs

Phase 4: Audit Closure

Module 3: The System Based Approach

Typical systems

1 min 17 secs

Quality assurance system

2 min 09 secs

Validation / qualification system

1 min 04 secs

Material system

1 min 45 secs

Premises and equipment systems

1 min 51 secs

Packaging and labelling systems

2 min 09 secs

Laboratory control systems (LIMS)

1 min 34 secs

Research and development systems (R&D)

1 min 42 secs

Engineering and maintenance systems

1 min 53 secs

Utilities systems

1 min 16 secs

Warehousing systems

1 min 54 secs

Module 4: The GMP Auditor

How to be a successful auditor

1 min 40 secs

Professional experience

1 min 44 secs

Knowledge and skills

1 min 29 secs

Audit principles

1 min 31 secs

Management systems and references

1 min 22 secs

Organizational situations

1 min 19 secs

Law and regulatory requirements

1 min 55 secs

Personal suitability

1 min 10 secs

Difficult situations

1 min 19 secs

Module 5: Examples of Audit Findings

Examples of GMP non-compliance

1 min 10 secs

Quality systems

1 min 30 secs

Facility systems

1 min 41 secs

Equipment systems

1 min 44 secs

Material systems

1 min 49 secs

Production and process control systems

1 min 51 secs

Packaging and labelling

1 min 30 secs

Laboratory control systems

1 min 22 secs

Organizational and personnel

1 min 15 secs

Records and reports

1 min 58 secs

Returned and salvaged products

1 min 09 secs

Conclusion

Final Assessment

shares

Author

Joginder Mittal

Joginder Mittal is a pharmaceutical GMP Expert with 20 years of extensive experience in cGMP aspects required during designing and setting up of Manufacturing Plants / Laboratories / R & D units. He has been involved in various projects for qualification activities and setting up of QMS Systems